Gene-Modified T Cells for Advanced Cancers

Recruiting in Palo Alto (17 mi)

Overseen by Philip McCarthy

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: Roswell Park Cancer Institute

No Placebo Group

Trial Summary

What is the purpose of this trial?

This phase I/IIa trial studies the side effects and best dose of gene-modified T cells when given with or without decitabine, and to see how well they work in treating patients with malignancies expressing cancer-testis antigens 1 (NY-ESO-1) gene that have spread to other places in the body (advanced). A T cell is a type of immune cell that can recognize and kill abnormal cells of the body. Placing a modified gene for NY-ESO-1 into the patients' T cells in the laboratory and then giving them back to the patient may help the body build an immune response to kill tumor cells that express NY-ESO-1. Drugs used in chemotherapy, such as decitabine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether giving gene-modified T cells with or without decitabine works better in treating patients with malignancies expressing NY-ESO-1.

Research Team

Philip McCarthy

Principal Investigator

Roswell Park Cancer Institute

Eligibility Criteria

This trial is for patients with advanced cancers like melanoma, ovarian, peritoneal or fallopian tube carcinoma, and synovial sarcoma that express the NY-ESO-1 gene. Participants need available tissue for testing or agree to a biopsy, have a caregiver nearby, meet medical criteria, use birth control, understand the study's nature and consent to it. They must not have brain metastases or severe autoimmune diseases.

Inclusion Criteria

Patients must understand the investigational nature of the study and provide informed consent

Patients must arrange for a caregiver available 24/7 and lodging within 45 minutes drive to the treatment center

My cancer is inoperable or has spread and falls into one of the specified categories.

Exclusion Criteria

You have had a serious autoimmune disease or inflammatory bowel disease in the past.

I am currently taking steroids or drugs that affect my immune system.

Pregnancy or breast-feeding

Treatment Details

Interventions

• Decitabine (DNA Methyltransferase Inhibitor)
• Gene-Modified T Cells (CAR T-cell Therapy)

Trial Overview The trial tests gene-modified T cells with/without decitabine in treating advanced malignancies expressing NY-ESO-1. It aims to find out how well these treatments work and their best doses by modifying patients' T cells to target tumor cells better.

Participant Groups

Group I: Cohort II (decitabine, cyclophosphamide, TCR/dnTGFbetaRII) Experimental Treatment 5 Interventions

Patients undergo leukapheresis on day -6 and receive decitabine IV over 1 hour on days -6 to -4 and cyclophosphamide IV over 2 hours on days -3 and -2. Patients then receive TGFbDNRII-transduced autologous tumor infiltrating lymphocytes IV over 15 minutes on day 0. Eligible patients who showed initial response/disease control, may receive a second TGFbDNRII-transduced autologous tumor infiltrating lymphocytes infusion at any time after progression is confirmed.

Group II: Cohort I (cyclophosphamide, TCR/dnTGFbetaRII) Experimental Treatment 4 Interventions

Patients undergo leukapheresis on day -6 and receive cyclophosphamide IV over 2 hours on days -5 and -4. Patients then receive TGFbDNRII-transduced autologous tumor infiltrating lymphocytes IV over 15 minutes on day 0. Eligible patients who showed initial response/disease control, may receive a second TGFbDNRII-transduced autologous tumor infiltrating lymphocytes infusion at any time after progression is confirmed.

Who Is Running the Clinical Trial?

Roswell Park Cancer Institute

Lead Sponsor

Trials

427

Recruited

40,500+

Dr. Julia Faller

Roswell Park Cancer Institute

Chief Medical Officer since 2024

DO from an unspecified institution

Dr. Candace S. Johnson

Roswell Park Cancer Institute

Chief Executive Officer since 2015

PhD in Immunology from The Ohio State University

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Dr. Douglas R. Lowy

National Cancer Institute (NCI)

Chief Executive Officer since 2023

MD from New York University School of Medicine

Dr. Monica Bertagnolli

National Cancer Institute (NCI)

Chief Medical Officer since 2022

MD from Harvard Medical School